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Vice President of Global Safety Operations

2 months ago

Waltham, Massachusetts, United States Apellis Full time
Job Overview

Position Summary:

The Vice President of Global Drug Safety and Pharmacovigilance serves as a pivotal safety physician and a prominent leader within the Global Development Organization. This role is essential for overseeing safety and pharmacovigilance across all active clinical trials, anticipated global product launches, and post-marketing initiatives. This is a highly influential position that engages with all levels of management and various functional areas, providing critical safety leadership and guidance on diverse organizational initiatives.

Key Responsibilities:

  • Direct a multidisciplinary, global team tasked with executing and monitoring comprehensive safety and pharmacovigilance strategies for products throughout all phases of development and commercialization.
  • Establish strategic Drug Safety and Pharmacovigilance plans and policies.
  • Oversee product safety surveillance strategies and manage the evolving safety profiles for clinical development programs and post-marketed products.
  • Lead the cross-functional product safety team, ensuring effective communication of safety issues to senior leadership as necessary.
  • Expand, direct, and support the operations of a global function overseeing products from Phase 3 through NDA/MAA submissions to approval and post-marketing.
  • Conduct routine pharmacovigilance activities for assigned programs, including the development of Reference Safety Information, aggregate safety reporting, signal detection, and literature reviews.
  • Draft and update the safety/risk sections in protocols, investigator brochures, and informed consent documents.
  • Formulate analysis strategies for the Integrated Summary of Safety (ISS) and benefit-risk content within Clinical Overview documents related to regulatory submissions.
  • Coordinate the design, development, and implementation of Risk Evaluation and Mitigation Strategies (REMS) among various stakeholders.
  • Advise on the design of post-approval safety studies.
  • Facilitate cross-functional collaboration within the organization to ensure adherence to safety standards.
  • Oversee the medical-safety sections of aggregate safety reports (DSUR, PSUR).
  • Support the successful implementation, execution, and maintenance of safety processes and systems that align with the company's strategic goals, industry standards, and global regulations.
  • Provide medical safety expertise for monitoring clinical trials and data safety monitoring boards.

Education and Qualifications:

  • MD or relevant advanced degree in health sciences with pertinent experience.

Professional Experience:

  • Over 10 years of experience in pharmacovigilance and drug safety.
  • In-depth knowledge of domestic and international regulatory safety reporting requirements for investigational and marketed products, including FDA/ICH guidelines related to pharmacovigilance and Good Clinical Practices, as well as familiarity with the Code of Federal Regulations regarding drug safety.
  • Proven leadership experience with a strong record of providing clear direction, overcoming obstacles, and developing talent.
  • Ability to review, synthesize, analyze, and effectively communicate complex safety data and clinical/pharmaceutical information.

Skills and Competencies:

  • Capability to design, lead, and manage a geographically dispersed, multi-functional organization effectively.
  • Exceptional interpersonal skills, with demonstrated abilities to work in a multidisciplinary environment, foster teamwork, and facilitate the achievement of corporate strategic objectives.
  • Outstanding written and verbal communication skills, with the ability to collaborate and build relationships with colleagues at various organizational levels.
  • Highly motivated and adaptable in a fast-paced environment.

Travel Requirements:

  • Up to 25% travel may be required.

Benefits:

Apellis offers a comprehensive benefits package, including health insurance with full premium coverage, a 401K plan with company matching, paid time off (PTO), long-term disability insurance, life insurance, and more.

Company Overview:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical organization dedicated to combining innovative science with compassion to develop transformative therapies for some of the most challenging diseases faced by patients. We have introduced the first new class of complement medicine in 15 years and currently have two approved therapies targeting C3, including the first and only treatment for geographic atrophy, a leading cause of blindness worldwide. With numerous clinical and pre-clinical programs in progress, we are committed to unlocking the potential of targeting C3 across various serious diseases.

Equal Employment Opportunity:

Apellis is an equal opportunity employer and adheres to all applicable federal, state, and local fair employment practices laws. We strictly prohibit discrimination against employees, applicants, or any other covered individuals based on race, color, religion, creed, national origin, ethnicity, sex, gender, age, disability, citizenship, and other protected characteristics.

Other Duties:

This job description is not intended to be an exhaustive list of all activities, duties, or responsibilities required of the employee for this position. Duties and responsibilities may change at any time with or without notice.